A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors

Summary

This is an open-label Phase 1 dose escalation study of OMP-21M18 in subjects with previously
treated solid tumors for which there is no remaining standard curative therapy and no
therapy with a demonstrated survival benefit. Up to 30 subjects will be enrolled at up to 4
centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,
biomarkers, and efficacy. No formal interim analyses will be performed. Prior to
enrollment, subjects will undergo screening to determine study eligibility. Upon
enrollment, subjects will receive weekly intravenous (IV) infusions of OMP-21M18 for 9
weeks. After 9 weeks of treatment, subjects will be assessed for disease status. If there
is no evidence of disease progression or if the tumor is smaller, then subjects may continue
to receive IV infusions of OMP-21M18 every other week until disease progression.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). The dose
levels of OMP 21M18 will be 0.5, 1.0, 2.5, 5, and 10 mg/kg administered IV weekly for 9
doses. No dose escalation or reduction will be allowed within a dose cohort. The dose may
be administered at any time during the day. Three subjects will be treated at each dose
level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experience a
DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a
DLT, no further subjects will be dosed at that level and 3 additional subjects will be added
to the preceding dose cohort unless 6 subjects have already been treated at that dose level.
Subjects will be assessed for DLTs from the time of the first dose through 7 days after
administration of the 4th dose, but prior to administration of the 5th dose (i.e., Days
0-28). Dose escalation, if appropriate, will occur after all subjects in a cohort have
completed their Day 28 DLT assessment.

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Medical and Biotech [MESH] Definitions

Lomustine

An alkylating agent of value against both hematologic malignancies and solid tumors.

Brenner Tumor

A smooth, solid or cystic fibroepithelial (FIBROEPITHELIAL NEOPLASMS) tumor, usually found in the OVARIES but can also be found in the adnexal region and the KIDNEYS. It consists of a fibrous stroma with nests of epithelial cells that sometimes resemble the transitional cells lining the urinary bladder. Brenner tumors generally are benign and asymptomatic. Malignant Brenner tumors have been reported.

Bleomycin

A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.

Mitomycins

A group of methylazirinopyrroloindolediones obtained from certain Streptomyces strains. They are very toxic antibiotics used as ANTINEOPLASTIC AGENTS in some solid tumors. PORFIROMYCIN and MITOMYCIN are the most useful members of the group.

Chromomycins

A complex of several closely related glycosidic antibiotics from Streptomyces griseus. The major component, CHROMOMYCIN A3, is used as a fluorescent stain of DNA where it attaches and inhibits RNA synthesis. It is also used as an antineoplastic agent, especially for solid tumors.

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